Longitudinal Bladder Cancer Study for Tumour Recurrence (LOBSTER)

November 6, 2025 updated by: Pacific Edge Limited

An Observational Study of CxBladder Monitoring for Recurrence of Urothelial Carcinoma in Low-, Intermediate-, and High-Risk Patients

Surveillance for recurrence of urothelial carcinoma (UC) requires frequent cystoscopy, which is invasive, expensive and time-consuming. An accurate urinary biomarker has the potential to reduce the number of cystoscopies required during post-treatment surveillance. This is a prospective, single arm, multi-center study using the diagnostic CxBladder test with subjects previously diagnosed with primary or recurrent UC and who are undergoing a schedule of investigative cystoscopies and treatment for the possible recurrence of UC presenting to qualified sites. To evaluate the performance characteristics of the CxBladder test, multiple consecutive urine samples will be collected during the course of surveillance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multi-site study recruiting subjects from Veterans Affairs and other medical centers. Subjects will be prospectively recruited to an observational study to validate the performance characteristics of CxBladder Monitor test (Monitor) and the second-generation test, CxBladder Monitor Plus (Monitor+). The study will recruit low, intermediate, and high-risk surveillance subjects, defined as per American Urological Association (AUA) / Society of Urologic Oncology (SUO) guidelines 2016 amendment 2020, previously diagnosed with urothelial carcinoma (UC). Eligible subjects will include those under surveillance for recurrence of UC. A voided urine sample will be collected from each enrolled subject at each of 4 successive surveillance visits. The collected urine will be used for CxBladder testing and central urine cytology. The study will collect primary tumour tissue from the first confirmed tumour, i.e., the primary diagnosis of UC (if available) and any subsequent collections within 12 weeks. Tissue samples from any UC recurrences while in study will also be collected to genotype each tumour using RNA or DNA markers indicative of an elevated risk of UC. Monitor/Monitor+ results will not be reported to patients or physicians. This study primarily aims to clinically validate the performance characteristics (sensitivity, specificity, negative predictive value, positive predictive value, and test-negative rate) of the Cxbladder Monitor/Monitor+ test compared to the reference standard i.e., tumours observed by cystoscopy and confirmed by pathology over a maximum of 4 surveillance visits. Sites are required to be competent in recruiting and completing required test request forms, Case Report Forms (CRF) and sample collection in a professional manner in accordance with good clinical practice (GCP).

Study Type

Observational

Enrollment (Estimated)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
  • United States
    • Florida
      • Miami, Florida, United States, 33125
        • Recruiting
        • Miami VA Healthcare System
        • Contact:
        • Principal Investigator:
          • Thomas Masterson
        • Sub-Investigator:
          • Mona Jahromi
      • Tampa, Florida, United States, 33612
        • Recruiting
        • James A. Haley Veteran's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cesar Ercole
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Recruiting
        • Ralph H. Johnson VA Health Care System
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen Savage
    • Texas
      • Dallas, Texas, United States, 75390
    • Vermont
      • White River Junction, Vermont, United States, 05009
        • Recruiting
        • White River Junction Veterans Affair Medical Center
        • Principal Investigator:
          • Florian Schroeck, MD
        • Contact:
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington School of Medicine
        • Principal Investigator:
          • Jonathan Wright, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study will recruit low-, intermediate-, and high-risk surveillance subjects (defined as per AUA/SUP Guidelines 2016, amendment 2020), previously diagnosed with urothelial carcinoma.

Description

Inclusion Criteria:

  1. Low-, intermediate-, and high-risk surveillance subjects with a previous confirmed diagnosis or recurrence of urothelial carcinoma within the last 3 calendar years.
  2. Subjects must agree to 4 successive study visits, including urine sample collection at each visit.
  3. Physically able to provide a voided urine sample (a sample from catheterization is not eligible).
  4. Able to give written informed consent
  5. Able and willing to comply with study requirements
  6. Aged 18 years or older

Exclusion Criteria:

  1. Total cystectomy of the bladder, subjects with neo-bladders or illeal conduits
  2. Previous muscle invasive bladder tumour (pT2 or greater)
  3. Known pregnancy

Deferral Criteria

  1. Prior genitourinary manipulation (catheterisation, urethral dilation, cystoscopy, etc.) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until a minimum of 14 calendar days has passed since the procedure was performed.
  2. Active urinary tract infection (UTI) within 14 calendar days of the scheduled urine collection, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred until the treatment is complete and the UTI is resolved.
  3. If a subject has had intravesical immunotherapy or chemotherapy within the previous 6 weeks, study enrollment with urine sample collection for Cxbladder Monitor testing should be deferred. Study enrollment must be at least 28 calendar days post-last treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single arm - Patients undergoing surveillance for UC recurrence
Subjects previously diagnosed with UC and are undergoing a schedule of surveillance cystoscopies and treatment for the possible recurrence of UC will be recruited. Low-, intermediate-, and high-risk groups, according to AUA /SUO risk categorisation for non-muscle invasive UC, will be eligible for this study. All subjects will undergo CxBladder urine diagnostic testing.
Diagnostic test: CxBladder Monitor/Monitor+
CxBladder Monitor/Monitor+ is a high sensitivity and negative predictive value (NPV) urinary biomarker test to rule-out subjects at low risk of bladder cancer monitoring for recurrence of disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To clinically validate the performance characteristics of CxBladder Monitor/Monitor+
Time Frame: 12 Months
To clinically validate the performance characteristics - sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and test-negative rate of Monitor and Monitor+ for the detection of recurrent UC in subjects with a recent history of urinary tract UC who are being treated according to standard of care and are concurrently undergoing routine investigative cystoscopy.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pacific Edge Limited

Investigators

  • Study Chair: Tony Lough, Pacific Edge Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2022

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 18, 2021

Study Record Updates

Last Update Posted (Estimated)

November 10, 2025

Last Update Submitted That Met QC Criteria

November 6, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXBM/2021/VA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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